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Trial registered on ANZCTR


Registration number
ACTRN12610001024033
Ethics application status
Approved
Date submitted
23/08/2010
Date registered
23/11/2010
Date last updated
23/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Benefits of A Tablet Combining Losartan and Hydrochlorothiazide in Hypertensive Patients with Diabetes
Scientific title
Safety and Benefits of A Tablet Combining Losartan and Hydrochlorothiazide in Hypertensive Patients with Diabetes
Secondary ID [1] 1090 0
Cochrane Renal Group (CRG) CRG010900155
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic patients with hypertension 243805 0
Condition category
Condition code
Cardiovascular 258196 258196 0 0
Coronary heart disease
Metabolic and Endocrine 258834 258834 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was performed by daily oral administration of losartan/hydrochlorothiazide combined tablet for 3 months.
The doses of losartan/hydrochlorothiazide were fixed throughout the study at 50mg/12.5mg/day.
This study was designed as a cross-over study. We did not have the washout period.
Intervention code [1] 257071 0
Treatment: Drugs
Comparator / control treatment
The study was performed by daily oral administration of losartan combined tablet for 3 months.
The doses of losartan were fixed throughout the study at 50mg/day.
This study was designed as a cross-over study. We did not have the washout period.
Control group
Active

Outcomes
Primary outcome [1] 240874 0
Serum levels of creatinine (Cr), cystatin C, potassium (K), uric acid (UA), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), glucose, and glycoalbumin (GA), and plasma levels of brain natriuric peptide (BNP), active renin concentrations (ARC), and aldosterone (PAC) were measured in venous blood samples, drawn in the morning after an overnight fast on the same days as the cardio-ankle vascular index (CAVI), augmentation index (AI), and blood pressure (BP) measurements were taken. Timepoints: 3 and 6 months
Timepoint [1] 240874 0
at 3 and 6 months from baseline
Secondary outcome [1] 257544 0
None
Timepoint [1] 257544 0
None

Eligibility
Key inclusion criteria
Diabetic patients who had untreated hypertension or uncontrollable hypertension treated with medications except for renin-angiotensin system (RAS) inhibitors.
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with serious refractory hypertension defined as more than 120 mmHg in diastolic BP, history of acute myocardial infarction, stroke, or any other cardiovascular events within 6 months, heart failure with New York Heart Association (NYHA) grade III, or grade IV, history of gout or hyperuricemia at the beginning of this study, kidney dysfunction defined as a serum creatinine level of more than 2 mg/dl, liver dysfunction defined as a serum transaminase level more than 3 times higher than normal, bilateral renal artery stenosis, secondary, or malignant hypertension, polycystic kidney disease, congenital kidney deformities, solitary kidney, pregnancy or probable pregnancy, history of allergy to the medication in this study, or those considered inappropriate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2127 0
Japan
State/province [1] 2127 0

Funding & Sponsors
Funding source category [1] 243705 0
University
Name [1] 243705 0
Keio University School of Medicine
Country [1] 243705 0
Japan
Primary sponsor type
University
Name
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
Country
Japan
Secondary sponsor category [1] 256748 0
Hospital
Name [1] 256748 0
Keio University School of Medicine
Address [1] 256748 0
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
Country [1] 256748 0
Japan

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30259 0
Address 30259 0
Country 30259 0
Phone 30259 0
Fax 30259 0
Email 30259 0
Contact person for public queries
Name 13506 0
A/Prof, Atsuhiro, Ichihara
Address 13506 0
Associate Professor, Endocrinology & Anti-Aging Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
Country 13506 0
Japan
Phone 13506 0
+81-3-5363-3796
Fax 13506 0
Email 13506 0
atzichi@sc.itc.keio.ac.jp
Contact person for scientific queries
Name 4434 0
A/Prof, Atsuhiro, Ichihara
Address 4434 0
, Endocrinology & Anti-Aging Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
Country 4434 0
Japan
Phone 4434 0
+81-3-5363-3796
Fax 4434 0
Email 4434 0
atzichi@sc.itc.keio.ac.jp

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.